Kornimate/medical-research-clean huggingface dataset:
a study to assess administration of an oral anti-thrombotic with antiplatelet therapy in healthy subjects

Conditions: Healthy Volunteers

Summary: this study will investigate the safety and interaction of bms-986177 in healthy volunteers, when administered with aspirin and/or clopidogrel


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * must have a body mass index (bmi) of 18.0 to 32.0 kg/m2, inclusive. * must have a normal renal function at screening as evidenced by an estimated glomerular filtration rate (gfr) of \> 80 ml/min/1.73 m2 calculated with the chronic kidney disease epidemiology collaboration formula and the absence of protein in the urine for parts 1 and 2: • must be a clopidogrel responder (eg, a decrease in platelet aggregation of at least 30% after a single 600-mg dose of clopidogrel compared with baseline). exclusion criteria: * any significant acute or chronic medical illness, including tinnitus or any other condition listed as a contraindication in the aspirin package insert. * history of dizziness and/or recurrent headaches (i.e. daily headaches lasting for 1 week's duration in the last month prior to study treatment administration). * history of head injury in the last 2 years, including participants with base skull fractures, intracranial tumor, or aneurysm. * history of gastroesophageal reflux disease, dyspepsia (indigestion), protracted nausea, or chronic diarrhea (defined as 3 or 4 loose stools per day that last for ≥ 4 weeks) within the past 6 months. other protocol-defined inclusion/exclusion criteria apply.
phase iii trial to evaluate the elortinib vs gefitinib in advanced nsclc with egfr exon 19 or 21 mutations

Conditions: Thoracic Neoplasms

Summary: this is a randomized controlled trial to compare efficacy and safety between erlotinib and gefitinib in advanced nsclc harboring egfr exon 19 or 21 mutations.eligible patients were randomized to receive erlotinib or gefitinib in any line settings.the primary endpoint was progression-free survival (pfs).

patients with stage iv nsclc who have egfr exon 19 or 21 mutations will randomized to received oral erlotinib 150mg or gefitinib 250mg once daily until disease progression or unacceptable toxicity. method of direct dna sequencing of tumor tissue is used to analysis egfr mutation status of exons 18-21. the response will be evaluated by recist criteria first month,second month and then repeat every 3 months after the beginning of the treatment weeks.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed stage iiib (wet) or iv nsclc. * patients with positive egfr exon19 or exon21 mutation as confirmed by direct sequencing histologically. * signing the informed consent form. * the vital organ functions are tolerant to therapy. * have recovered to ctcae2 grade below from toxicity of previous chemotherapy and radiotherapy * ps 0-2 scores. * functional reserve of bone marrow is adequate, e.g. white blood cell count ≥3.0×109/l, planet count ≥90×109/l, and hb≥80×109/l. * serum bilirubin is 2 times less than the upper limit of normal (uln), alt and ast are 3 times less than uln; for liver metastases, alt and ast need to be 5 times less than uln; creatinine should be 2 times less than uln. exclusion criteria: * informed consent is not provided. * women of pregnancy or breastfeeding. * have difficulty in swallowing.

Keywords: thoracic neoplasms molecular mechanisms of pharmacological action protein kinase inhibitors respiratory tract diseases lung neoplasms erlotinib gefitinib epidermal growth factor receptor genes
evaluate the efficacy and safety of tolnaftate cream in the treatment of patients with fungal infections

Conditions: Fungal Infections; Tinea Pedis; Tinea Cruris; Tinea Corporis

Summary: this is a study clinical, multicenter, phase iii trial, to evaluate the efficacy and safety of tolnaftate cream in the treatment of patients with fungal infections such as tinea foot, tinea and tinea crural body.

study clinical, multicenter, phase iii, to evaluate the efficacy and safety of 10mg/g tolnaftate cream in the treatment of patients with fungal infections such as tinea foot, tinea and tinea crural body.

Eligibility criteria:
inclusion criteria: * patients of both sexes, of any race, aged 12 years; * ability to understand and sign the ic (for patients older than age) in the case of minors monitoring and consent of a guardian; * clinical diagnosis of fungal infections for tinea pedis (ringworm of the feet) or tinea cruris (ringworm of the groin region), or tinea corporis (ringworm in other body areas); * direct mycological exam positive for fungi; exclusion criteria: * pregnant women or nursing mothers; * use of topical or oral antifungal; * use of steroids; * allergy or hypersensitivity to any component of product; * clinical cases of tinea infection by bacteria and / or eczema, tinea extensive and onychomycosis.

Keywords: fungal infections tinea tonaftato
treatment of chronic migraine headaches.

Conditions: Chronic Migraine Without Aura, Intractable; Migraine With Typical Aura; Migraine Disorders

Summary: the purpose of the study is assessment of the safety and efficacy of the de-novo therapy in the treatment of craniofacial neuralgia and migraine headaches.this is an open-label study of simultaneous administration of combination of dexamethasone, lidocaine, and thiamine into the trigeminal nerve branches as well as greater and lesser occipital nerve bilaterally in one session. patients who meet the exclusion and inclusion criteria are eligible for trial if they have experienced chronic migraine and craniofacial pain not responding to other prior therapies.

a combination of dexamethasone, lidocaine and thiamine (pat.), may bring changes in the pattern of sympathetic and parasympathetic nerve signaling at the level vasa nervorum. these changes may down-regulate the hyperexcitable sympathetic signals at the level of adventitia and consequently the medial layer of vasa nervorum and providing long term relief from migraine headaches. however, a bilateral and simultaneous treatment of trigeminal and occipital nerves in migraine and craniofacial neuralgia using a combination of dexamethasone, thiamine and lidocaine has been rarely studied. the objective of this study is to assess the safety and efficacy of concomitant administration of dexamethasone, lidocaine, and thiamine compounds into the trigeminal nerve branches, the greater and lesser occipital nerve for the treatment of chronic migraine, and craniofacial neuralgia.

Eligibility criteria:
inclusion criteria: * • age: 10-90 years * ability to describe headache and its symptoms * ability to read, comprehend, and legibly and reliably record information * ability to provide written, informed consent, and respond to pre and post treatment questionnaires, children's guardian accepts responsibility. willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures * already diagnosed with chronic craniofacial neuralgia and chronic migraine headache * exhausted all or most of available abortive and preventive treatment modalities. exclusion criteria: * • uncontrollable hypertension, acute myocardial infarct within last 6 months * history of cerebral vascular aneurysm/known atherosclerosis of cerebral system, brain tumor * implanted of neuro-stimulator, trigeminal tractotomy, neurectomy partial or complete, history of gamma knife treatment, microsurgical decompression procedure. * hypersensitivity or allergy to any components of de-novo formula * presence or known anatomic craniofacial deformities or severe spondylosis/spondylolisthesis of cervical spine, profound dental caries, maxillofacial deformities * pregnancy and current breast feeding status * headaches attribute to acute head and neck injuries, chronicity of cervicogenic headaches * skin infection or micro abscesses dermatogen or dental, ongoing treatment for methicillin resistant streptococcus aureus ( mrsa) unless treatment completed.

Keywords: migraine craniofacial neuralgia
somatosensory tinnitus study

Conditions: Tinnitus

Summary: somatosensory tinnitus is suspected when the tinnitus perception changes following head, neck, or jaw maneuvers. the prevalence of this type of tinnitus in veterans in unknown. the cleveland clinic evaluates all tinnitus patients for this condition and when detected, prescribes individualized physiotherapy. cleveland clinic's novel approach to tinnitus assessment and management provides the framework for this proof of concept pilot study.

phase 1a involves adapting cleveland clinic's assessment and treatment approach for somatosensory tinnitus to make it feasible for a va population. phase 1b involves screening veterans with tinnitus to evaluate and describe the prevalence of somatosensory tinnitus (in veterans with tinnitus). phase 2 involves veterans with somatosensory tinnitus receiving 3 individualized physical therapy sessions using the adapted approach developed during phase 1a. phase 3 will evaluate the feasibility and tolerability of the adapted treatment approach.

Eligibility criteria:
inclusion criteria: * veteran * chronic tinnitus * positive screen for somatosensory tinnitus exclusion criteria: * non-veteran * participation in new (\< 1 month) tinnitus management or treatment * current participation in tinnitus research involving an intervention

Keywords: tinnitus
intelligent volume assured pressure support to improve sleep quality and respiratory events in patients with non invasive ventilation

Conditions: COPD; Chronic Hypercapnic Respiratory Failure

Summary: aim of this prospective randomized trial is to compare non invasive ventilation (niv) with pressure control (bipap-st) to volume assured pressure support (ivaps) with regards to sleep quality and alveolar ventilation in patients with routine niv initiation after copd exacerbation. 20 patients with copd and chronic hypercapnic respiratory failure will spent two nights on niv, one with spontaneous timed pressure controlled bilevel ventilation (bipap-st) and one with the advanced mode of intelligent volume assured pressure support (ivaps). patients will spend the treatment nights in randomized order under polysomnographic surveillance, including transcutaneous pco2 measurement. besides the number of arousals and pco2 values over night the sleep quality will be judged with regards to especially adjusted respiratory event criteria like unintentional leaks, patient ventilator asynchrony, and decrease of ventilatory drive.

non invasive ventilation (niv) is one of the major medical innovations of the last 30 years. especially continuous positive airway pressure (cpap) is the established gold standard in obstructive sleep apnea (osa) treatment. niv with bilevel ventilation (bipap-st) is the established gold standard in acute hypercapnic respiratory failure, especially in exacerbated copd. still, the adaption of cpap in osa is less complicated than a bilevel therapy in hypercapnic failure. the adjustment of niv requires not only the definition of expiration pressure (peep) but also of inspiration pressure support. only adequate pressure difference guarantees effective ventilatory assistance and an improvement of alveolar ventilation. the pressure changes need to be defined by the physician, as well as the breathing frequency. ventilation can furthermore be controlled by a target volume (volume controlled) or a target pressure (pressure controlled). moreover, patients with respiratory insufficiency are often suffering of significant dyspnoea and are hard to accustom to a respiratory mask. there is a lack of systematic studies addressing the effects of different ventilator settings on sleep and life quality, as well as studies about the necessary monitoring extent during the niv initiation.

Eligibility criteria:
inclusion criteria: * stable respiratory insufficiency * hypercapnia \>50 mmhg * clinically required niv * capable of giving consent exclusion criteria: * existing ventilatory support * invasive ventilation * any other severe physical disease that requires immediate medical assistance * acute hypercapnic decompensation with ph \<7.30 in routine bga * circumstances that doesn't allow mask ventilation (e.g. facial deformation) * participation in a clinical trial within the last 4 weeks * pregnancy or nursing period * drug addiction

Keywords: copd chronic hypercapnic respiratory failure niv respiratory events ivaps
tolerance and prebiotic activity of arabinoxylan-oligosaccharides in healthy subjects

Conditions: Healthy

Summary: the purpose of the study is to evaluate the tolerance of a higher dose of arabinoxylan-oligosaccharides (axos) and their prebiotic activity in healthy subjects.


Eligibility criteria:
inclusion criteria: * healthy * 18-45 years * regular eating pattern exclusion criteria: * gastrointestinal complaints * antibiotic intake * medication influencing gut transit or microbiota * abdominal surgery * pregnancy

Keywords: tolerance prebiotic gastrointestinal effects
a study of jr-141 in patients with mucopolysaccharidosis ii

Conditions: Mucopolysaccharidosis II

Summary: a phase ii open-label, randomized, parallel group, 2 sites (brazil), designed to evaluate the safety and efficacy of 3 doses of study drug for the treatment of the mps ii.


Eligibility criteria:
inclusion criteria: * males with confirmed diagnosis of mps ii, based on deficient activity of ids in leucocytes or fibroblasts and/or pathogenic mutations identified in the ids gene (if enzyme diagnosis was in dried blood spots or plasma, molecular genetics confirmation is mandatory). * one of the following age groups: 1. 0 to 3 years and 11 months old (6 patients, 2 in each dose) 2. 4 years to 7 years and 11 months old (6 patients, 2 in each dose) 3. 8 years or older (6 patients, 2 in each dose) * capable of providing written consent by himself, unless the patient is under the age of 18 years at the time of informed consent process, or it is not possible to obtain consent from the patient himself due to his intellectual disabilities associated with mps ii. * in the case of a patient who is under the age of 18 years or from whom it is not possible to obtain consent due to his intellectual disabilities associated with msp ii, he may be included if written consent can be provided by legal representative; however written consent should be obtained from the patient himself too, wherever possible. * naïve patients or patients who are receiving enzyme replacement therapy with idursulfase could be included if provided treatment has been stable in the last 6 months and agree to interrupt the treatment at least one week before the first study drug infusion, and agree in suspending this treatment for the duration of the trial. exclusion criteria: * refusal to sign the informed consent form. * unable to perform the study procedures, except for neurocognitive testing. * previous engrafted bmt/hsct. * surgical or other major medical intervention planned to occur before week 26. * participation in a clinical trial with an investigational drug in the last 12 months. * judged by the investigator or subinvestigator as being unable to undergo lumbar puncture, including those who have difficulties in taking a position for lumber puncture due to joint contracture or those who are likely to experience difficulty breathing during the lumbar puncture process. * judged by the investigator or subinvestigator to be ineligible to participate in the study due to a history of a serious drug allergy or sensitivity. * otherwise judged by the investigator or subinvestigator to be ineligible to participate in the study out of consideration for the subject safety.
a study to assess csf1r-related leukoencephalopathy after stem cell transplantation

Conditions: CSF1R-related Leukoencephalopathy; ALSP; POLD; Hematopoietic Stem Cell Transplantation

Summary: the purpose of this study is to measure the effect of hematopoietic stem cell transplantation (hsct) on symptoms of csf1r-related leukoencephalopathy.

the purpose of this study is to measure the effect of hematopoietic stem cell transplantation (hsct) on symptoms of csf1r-related leukoencephalopathy.

Eligibility criteria:
inclusion criteria: * ≥ 18 years of age. * genetic confirmation of a mutation in the csf1r gene. * diagnosis of csf1r-related leukoencephalopathy. * anticipated to undergo haematopoietic stem cell transplantation (hsct). exclusion criteria: * concurrent diagnoses that may confound neuropsychological testing; e.g., major hearing/visual impairment. * concurrent diagnoses that may confound ambulatory measurements; e.g., amputee. * inability to undergo magnetic resonance imaging (mri); e.g., mr-incompatible implant.

Keywords: hdls, leukoencephalopathy
efficacy of inspiratory muscle training on inspiratory capacity in patients with copd

Conditions: COPD

Summary: hypothesis:benefits of inspiratory muscle strenght training with respifit s decreases symptoms, disability or handicap of patients affected by copd. the inspiratory fraction (inspiratory capacity ic/ total lung capacity tlc)may be functionally more representative than other traditional indices.


Eligibility criteria:
inclusion criteria: * copd gold ii-iii (fev1\ 30%) exclusion criteria: * pregnancy * lung cancer * diabetes mellitus * primary exacerbation of copd

Keywords: copd inspiratory muscle training if
efficacy of methylsulfonylmethane supplementation on osteoarthritis of the knee: a randomized controlled study

Conditions: Knee Osteoarthritis

Summary: the aim of this study was to determine the efficacy of methylsulfonylmethane (msm) in treating patients with knee oa.


Eligibility criteria:
inclusion criteria: * symptomatic knee oa for at least 6 months according to the clinical criteria of the american college of rheumatology (acr) * radiographic confirmed knee oa according to the kellgren \& lawrence scale exclusion criteria: * acute septic arthritis * inflammatory arthritis * any other type of arthritis * history of knee buckling or recent knee injury * lack of physical or mental bility to perform or comply with the treatment procedure * diabetes mellitus * fibromyalgia or other chronic pain syndromes * concurrent anti-coagulant/anti-platelet drugs * arthroscopy or intra-articular injections in the previous 3 months
a study of the safety and efficacy of bimatoprost ophthalmic solution in paediatric patients with glaucoma

Conditions: Glaucoma

Summary: the purpose of this study is to assess the safety and efficacy of a new formulation of bimatoprost ophthalmic solution compared to timolol ophthalmic solution in the treatment of paediatric patients with glaucoma.


Eligibility criteria:
inclusion criteria: * diagnosis of congenital, juvenile glaucoma * requires treatment with iop-lowering medication in one or both eyes exclusion criteria: * surgical intervention is indicated or planned to lower iop * abnormally low body weight (below 5th percentile) * any active eye infection or disease * anticipated use of contact lenses during the study * topical ocular steroid use within 2 months * history of ocular trauma in either eye * required chronic use of ocular medications (other than study medication) during the study (intermittent use of artificial tears permitted)
docetaxel+carboplatin vs epirubicin+cyclophosphamide followed by docetaxel as adjuvant treatment in triple-negative breast cancer

Conditions: Breast Cancer

Summary: triple-negative breast cancer (tnbc) has a relatively bad prognosis whereas there is no standard regimen. some data showed that platins could improve the efficacy of advance tnbc. in this trial, it is the hypothesis that tp (docetaxel plus carboplatin) has a better efficacy than ec-t (epirubicin plus cyclophosphamide followed by docetaxel).


Eligibility criteria:
inclusion criteria: * triple-negative breast cancer * older than 18 years old * have tumor resection surgery * sufficient organ function (marrow, heart, liver) exclusion criteria: * other malignancy * other serious disease( marrow, heart, liver)

Keywords: triple-negative breast cancer
diafert for embryo selection and fertility improvement (destiny)

Conditions: Infertility

Summary: prospective, single-center, single-blind, randomized, controlled, two-arm, interventional study.


Eligibility criteria:
inclusion criteria: 1. women at least 18 years old at the time of informed consent. 2. able to understand and voluntarily sign an informed consent form approved by the relevant independent ethics committee (iec) governing the site. 3. first or second fresh assisted reproductive technology (art) cycle attempt (since last successful implantation, if any). 4. eligible for elective set of fresh embryo on day 2/3. elective set is defined as a transfer for which there is more than one embryo in the same morphological ("best") category as that of the selected embryo. exclusion criteria: 1. presence or history of ovarian endometriotic cyst. 2. presence or history of diagnosed severe endometriosis (i.e. stage iv of the revised american fertility society classification for endometriosis). 3. hormonal, functional, anatomical and/or other abnormalities potentially increasing the risk of miscarriage and/or ectopic pregnancy as judged by the investigator and determined by medical history and clinical laboratory. this includes, but is not limited to, uncontrolled diabetes mellitus, uncontrolled thyroid disease, alcoholism, drug abuse, abnormal uterine cavity etc. 4. history of two or more consecutive miscarriages. 5. known history of human immunodeficiency virus, hepatitis c virus and/or hepatitis b virus infection. 6. the subject has other serious or acute conditions that, in the investigator's opinion, would preclude her participation in the study. 7. need for preimplantation genetic diagnosis/screening. 8. use of time-lapse embryo imaging 9. participating in oocyte donation procedure. 10. participation in any interventional drug clinical investigation within 2 months prior to screening. 11. dependency on sponsor or investigator (e.g. co-worker or family member).

Keywords: embryo transfer embryo selection criteria for implantation assisted reproductive technology